This invention relates to the field of human medicine, more specifically to dermatology, and in particular to a composition developed for stimulating the synthesis of the melanic pigment of the skin, therefore useful in the treatment of vitiligo, as well as the procedure for obtaining that composition.
Vitiligo or leukoderma is one of the oldest known diseases of humanity, and is characterized by the loss of the cells that produce melanic pigment in the skin. This disease affects approximately 1% of the world""s population, without distinction as to age, sex or race. It is of unknown etiology and no treatment has been found for it up to now. It appears as a gradual depigmentation of the skin of patients who are in situations of extreme nervous tension, and has an unfavorable affect on their psyche and social behavior as its external symptoms emerge, appearing as white areas of skin surrounded by a halo of hyperpigmentation, and manifesting themselves primarily on the face, trunk and around the joints.
Current technology recognizes that certain chemical substances of vegetable origin or produced semi-synthetically, known as psoralens, can be used in the treatment of vitiligo. These substances, administered orally or topically, concentrate in the melanocytes or cells that produce the dermic pigment, absorbing energy from ultraviolet radiation and stimulating the production of the pigment melanin. (Arnold, M. J. Jr. xe2x80x9cPsoralens and Suntan,xe2x80x9d Hawaii Med. J., 1957-16391); (Becker, S. W. Jr. xe2x80x9cMethods of Increasing Skin Pigmentation,xe2x80x9d J. Sec. Cosmetic Ehem., 1958-9-80); (Fitzpatrick, T.B. xe2x80x9cPigmentary Diseases,xe2x80x9d Current Therapy, 1958-314); (Becker, S. W. Jr. xe2x80x9cEffects of 8-Methoxy Psoralen and Ultraviolet Light in Human Skin,xe2x80x9d Science, 1958-127-878); (Sidi, E. Planat, P. xe2x80x9cPractical Considerations on Current Treatment of Vitiligo,xe2x80x9d Revue of Medicine, Dec. 23, 1968).
However, psoralens are not without toxic secondary effects, being capable of causing dermatitis and necrosis of the skin when applied topically. Furthermore, their effect is slow and reversible in the majority of cases when the medication is discontinued. In addition, these substances present some difficulties in application, which requires a gradually increasing daily period of ultraviolet radiation exposure for the patient, sometimes provoking severe toxic reactions such as burns resulting from their topical application, or hepatic insufficiency, digestive, renal and nervous disturbances from their oral administration.
The currently known technical solution that is most similar to this invention is Melagenina Lotion(copyright), Patent FR 8220746. Melagenina Lotion(copyright) is a 50% human placenta alcoholic extract, which is obtained from healthy pregnant women under aseptic conditions after normal childbirth. This extract contains a lipoprotein with a molecular weight between 1500 and 4000 Daltons, which constitutes its active element. This substance stimulates the reproduction of the melanocytes and the synthesis of the melanic pigment, also accelerating the oxidation of the amino acid L-dopa in the presence of sunlight, which encourages its transformation into melanin after internal chemical processes.
Melagenina Lotion(copyright) has been used successfully for the treatment of vitiligo up to now. According to clinical trials that were performed, its use was noticeably effective among all the patients to whom it was applied. (Miyares Cao C., Taboas M. and Lxc3x3pez H. xe2x80x9cInforme preliminar sobre el empleo de extracto placentario humano en la terapeutica del Vitiligo,xe2x80x9d [Preliminary Report on the Use of Human Placenta Extract in the Treatment of Vitiligo] Revista Cubana de Farmacia 10 (1). 1976; Miyares Cao C. et al. xe2x80x9cEstudio experimental y clinico del efecto pigmentante epidermico del extracto placentario humano,xe2x80x9d [Experimental and Clinical Study of the Epidermal Pigmenting Effect of Human Placenta Extract] Revista Cubana de Farmacia, Volume 20, No. 6, November-December 1981; Sharma S. K.,. Jain R. K and Sharma A. K. xe2x80x9cTopical Human Placental Extract for the Treatment of Vitiligo, A Preliminary Studyxe2x80x9d; Miyares C. et al., xe2x80x9cEstudio experimental y clinico del efecto pigmentante epidermico del extracto placentario humano,xe2x80x9d[Experimental and Clinical Study of the Epidermal Pigmenting Effect of Human Placenta Extract] Annais Brasileiros de Dermatologia, 1986: 61: 3 (Supplement); Miyares Cao C. xe2x80x9cMelagenina Producto Cubano. Nuevo y Eficaz medicamento para el tratamiento del Vitiligo,xe2x80x9d [The Cuban Product Melaginina. A New and Effective Medication for the Treatment of Vitiligo] Serie de Resenas Nacionales, Ed. Palacio de las Convenciones. Havana, p. 15. 1986).
Melagenina Lotion(copyright), although free of harmful side effects, is a product that must be used in three daily applications at 8-hour intervals and accompanied by sun or infrared exposure at one of the applications, which makes it difficult for many of the patients to complete the treatment.
Current technology also recognizes that calcium actively participates in the process of skin pigmentation, through the stimulation of the secreting action of the melanocytes in proportion to the concentration of this ion. (Meyer, A. 1986. xe2x80x9cInfluence of Calcium on the Melanocytes in the Inner Ear,xe2x80x9d Abst; 13th International Pigment Cell Conference Oct. 5-6, Tucson, Ariz., USA; and Negishi, S. 1986. xe2x80x9cThe Role of Calcium in Light Response of Onyzias Melonophores,xe2x80x9d Abst; 13th International Pigment Cell Conference Oct. 5-6, Tucson, Ariz., USA).